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6624-65-25

by Zimmer, Inc.

Ref 00-6624-065-25

6624-65-25 (00-6624-065-25) is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI B-00889024127654), cleared under FDA 510(k) K921308 on 22 Feb 1994 (1 earlier submission) and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00889024127654), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

9 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K921308

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024127654 Basic UDI-DI 00889024127654UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024127654 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK921308 Date22 Feb 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024127654 registered 31 Oct 2026 Active
  • FDA 510(k) K921308 decided 22 Feb 1994 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024127654 listed 17 Sep 2015 Listed

Recalls

9 recalls · FDA

    • Terminated Z-1683-2016 FDA Class II initiated 4 May 2016 on shared 510(k) K840643

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

  • 4 recalls, same reason

    • Terminated Z-1137-2016 FDA Class II initiated 11 Jan 2016 on shared 510(k) K840643
    • Terminated Z-1131-2016 FDA Class II initiated 11 Jan 2016 on shared 510(k) K840643
    • Terminated Z-1110-2016 FDA Class II initiated 11 Jan 2016 on shared 510(k) K840643
    • Terminated Z-1126-2016 FDA Class II initiated 11 Jan 2016 on shared 510(k) K840643

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

  • 4 recalls, same reason

    • Terminated Z-1026-2014 FDA Class II initiated 11 Oct 2013
    • Terminated Z-1025-2014 FDA Class II initiated 11 Oct 2013 on shared 510(k) K840643
    • Terminated Z-1033-2014 FDA Class II initiated 11 Oct 2013 on shared 510(k) K840643
    • Terminated Z-1036-2014 FDA Class II initiated 11 Oct 2013 on shared 510(k) K840643

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-1025-2014
  2. Recall initiated FDA recalls Z-1033-2014
  3. Recall initiated FDA recalls Z-1036-2014
  4. Listed FDA GUDID 00889024127654
  5. Recall initiated FDA recalls Z-1137-2016
  6. Recall initiated FDA recalls Z-1131-2016
  7. Recall initiated FDA recalls Z-1110-2016
  8. Recall initiated FDA recalls Z-1126-2016
  9. Recall initiated FDA recalls Z-1683-2016
  10. Registered EUDAMED B-00889024127654

3 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
HP Acetabular Screws_HGP II BONE SCREW 6.5 Implants
Model / Ref / Catalog
00-6624-065-25, 6624-65-25
Primary DI / UDI-DI
00889024127654
Basic UDI-DI
B-00889024127654
510(k) Number
FDA product code
LPH
EMDN code
P09088099 Hip prostheses - other accessories
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3358
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 25 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-6624-065-25
GUDID
6624-65-25
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K840643)

and 8 more cleared under K840643

Cleared under the same submission (K921308)

and 8 more cleared under K921308

Similar devices in this category

Other devices filed under HIP PROSTHESES - OTHER ACCESSORIES.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)